Bleximenib AME in Participants with Acute Leukemia
Research type
Research Study
Full title
An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants with Acute Leukemia
IRAS ID
1012471
Contact name
Elena Bolanas
Contact email
Sponsor organisation
Janssen-Cilag International NV
ISRCTN Number
ISRCTN90362708
Research summary
Acute leukemias are highly aggressive blood cancers characterized by uncontrolled proliferation of iimmature white blood cells in the bone marrow, peripheral blood and/or other sites in the body. Although treatment options are available, some participants either do not respond or may not be able to tolerate them because of their side effects. Hence, there is a need for better treatments. Bleximenib is a medicine that specifically targets and blocks the interaction between the proteins histone-lysine N-methyltransferase 2A (KMT2A) and menin which has been shown to be responsible for the worsening of acute leukemias with KMT2A, nucleophosmin 1 (NPM1, NUP 98 or NUP214 gene alterations. Blocking this interaction kills cancer cells and stops the disease from worsening. In this study, researchers want to determine how radiolabeled (14-C) bleximenib is absorbed, broken down and removed from the body. Participants will be aged 18 years or older with relapsed or refractory acute leukemia with KMT2A, NPM1, NUP98, or NUP214 gene alterations. Study consists of:
1. Screening phase (up to 30 days)
2. Open-label treatment phase (up to 28 days): Participants will receive a single oral dose of 14C-bleximenib on Day 1. On Day 2, participants will receive non-radiolabeled bleximenib at a safe and effective dose (recommended phase 2 dose [RP2D]) twice daily until Day 28.
Eligible participants may have the option to join 75276617ALE1001 (NCT04811560) study for continued treatment with non-radiolabeled bleximenib.
3. Safety follow-up phase (up to 30 days after last dose of non-radiolabeled bleximenib until transition to 75276617ALE1001 study [as applicable] or until start of subsequent anticancer therapy, whichever occurs first). Safety assessments will include monitoring adverse events, physical examinations, clinical laboratory tests and eastern cooperative oncology group performance status (measures how well participants live). Overall duration of the study will be ~28-58 days.REC name
Wales REC 1
REC reference
25/WA/0248
Date of REC Opinion
7 Oct 2025
REC opinion
Further Information Favourable Opinion